SDT

Intra-Pulmonary Percussive Vibration (Ipv) Devices

Product code
SDT
Device name
Intra-Pulmonary Percussive Vibration (Ipv) Devices
Device class
Class 2
21 CFR
21 CFR 868.5665
Medical specialty
Anesthesiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3

FDA classification definition

It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-12-23.

NumberDecision dateApplicantDevice nameSummary
K2410912024-12-23Inogen, Inc.SIMEOX 200 Airway Clearance DevicePDF

1 summaries are archived here for direct download.

Official FDA classification page: SDT
Classification and pathway per current FDA publications. Data from openFDA (CC0).